Thorac Cardiovasc Surg 2018; 66(S 01): S1-S110
DOI: 10.1055/s-0038-1627857
Oral Presentations
Sunday, February 18, 2018
DGTHG: Coronary Heart Disease II
Georg Thieme Verlag KG Stuttgart · New York

Randomized Clinical Trial on Carotid Endarterectomy in Patients with Asymptomatic Carotid Artery Stenosis Undergoing Coronary Artery Bypass Grafting (CABACS)

S. C. Knipp
1   Department of Thoracic and Cardiovascular Surgery, University Hospital Essen, West German Heart and Vascular Center, Essen, Germany
,
T. Holst
1   Department of Thoracic and Cardiovascular Surgery, University Hospital Essen, West German Heart and Vascular Center, Essen, Germany
,
J. Rekowski
2   Institute for Medical Informatics, Biometry and Epidemiology, University Hospital Essen, Essen, Germany
,
K. Bilbilis
3   Center for Clinical Trials, University Hospital Essen, Essen, Germany
,
A. Scherag
4   Department of Clinical Epidemiology, Center for Sepsis Control and Care, Jena University Hospital, Jena, Germany
,
H. C. Diener
5   Department of Neurology, University Hospital Essen, Essen, Germany
,
H. Jakob
1   Department of Thoracic and Cardiovascular Surgery, University Hospital Essen, West German Heart and Vascular Center, Essen, Germany
,
C. Weimar
5   Department of Neurology, University Hospital Essen, Essen, Germany
› Author Affiliations
Further Information

Publication History

Publication Date:
22 January 2018 (online)

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Objectives: The optimal strategy to manage patients with severe carotid artery disease who require coronary artery bypass grafting (CABG) is unknown. We sought to investigate the safety and efficacy of synchronous combined carotid endarterectomy (CEA) and CABG as compared with isolated CABG.

Methods: The present trial was an investigator-initiated, randomized, controlled, open, multi-center, group sequential trial (CABACS). Patients were recruited from 12/2010 through 12/2014 in 17 tertiary care cardiovascular centers in Germany and the Czech Republic. Patients with high-grade carotid artery stenosis ≥80% according to ECST ultrasound criteria (corresponding to ≥70% NASCET) who required CABG surgery were assigned to synchronous CEA+CABG or isolated CABG using a web-based stratified block randomization (1:1, stratified by center, age < 60 versus ≥60 years, sex, modified Rankin Scale Score 0–1 versus 2–3). The primary composite endpoint was the rate of stroke or death at 30 days.

Results: Due to withdrawal of funding following insufficient recruitment, enrollment was terminated early. At 30 days, the rate of stroke or death from any cause in the intention-to-treat population was 12/65 (18.5%) in patients receiving synchronous CEA+CABG as compared with 6/62 (9.7%) in patients receiving isolated CABG (absolute risk reduction, 8.8%; 95% confidence interval [CI], −3.2–20.8%; pWALD=0.12). Also for all secondary endpoints at 30 days, there was no evidence for a treatment group effect although patients undergoing isolated CABG tended to have better outcomes. For instance, the composite rate of stroke, myocardial infarction or death was 12 (18.5%) after CEA+CABG as compared with 7 (11.3%) after isolated CABG (Hazard ratio [HR], 1.64; CI, 0.69–3.88; p = 0.32). At 1 year, there were more strokes after synchronous CEA+CABG but the difference was not significant (11 [18.3%] versus 4 [7.0%]; HR, 2.61; CI, 0.88–7.73; p = 0.10).

Conclusions: Although our results cannot rule out a treatment group effect due to lack of power, a superiority of the synchronous combined CEA+CABG approach seems unlikely. Five-year follow-up of patients is still ongoing.

Clinical Trial Registration: ISRCTN13486906.